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NCT03444844 · ClinicalTrials.gov registry record · Phase 1
Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer
A Phase 1 study of Prostate Cancer and Prostate Cancer Recurrent, sponsored by Five Eleven Pharma.
- Active
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03444844: Active Phase 1 study of Prostate Cancer and Prostate Cancer Recurrent, sponsored by Five Eleven Pharma.
NCT03444844 is a Phase 1 study of Prostate Cancer and Prostate Cancer Recurrent that is active but no longer recruiting, run by Five Eleven Pharma. The registered enrollment target is 60 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03444844, a Phase 1 study of Prostate Cancer and Prostate Cancer Recurrent, is active but no longer recruiting, sponsored by Five Eleven Pharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Initial performance of Ga-68-P16-093 in prostate cancer patients including dosimetry and preliminary efficacy evaluation in BCR patients, and correlation of Ga-68-P16-093 uptake with tissue histopathology in intermediate to high risk primary prostate cancer patients.
Primary Outcome
We will compare the number and location of metastatic lesions apparently detected by 68Ga-P16-093 with the number and location of lesions detected by standard-of-care imaging. Sensitivity of the 68Ga-P16-093 PET procedure will be estimated based on the number of subjects in whom a site of disease is identified by the imaging procedure. Scans will also be reconstructed summing passes 1-5, passes 2-5, passes 3-5, and passes 1-2 to assess how image quality varies with chosen framing.
Conditions Studied
Interventions
- DRUG Ga-68 P16-093 PET/CT scan
Study Locations (1)
Indiana
- Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2018-05-10 |
| Est. Completion | 2022-07 |
| Phase | Phase 1 |
What the registry record for NCT03444844 still lists
NCT03444844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Ga-68 P16-093 PET/CT scan is the first listed.
NCT03444844 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT03444844 about?
NCT03444844 is a clinical study titled "Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer". Initial performance of Ga-68-P16-093 in prostate cancer patients including dosimetry and preliminary efficacy evaluation in BCR patients, and correlation of Ga-68-P16-093 uptake with tissue histopathology in intermediate to high risk primary prostate cancer patients.
What is the current status of trial NCT03444844?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2018-05-10. Estimated completion is 2022-07.
What conditions does trial NCT03444844 study?
This clinical trial studies the following conditions: Prostate Cancer, Prostate Cancer Recurrent.
What interventions are being tested in trial NCT03444844?
The interventions under investigation include: Ga-68 P16-093 PET/CT scan (DRUG).
Who is sponsoring clinical trial NCT03444844?
This trial is sponsored by Five Eleven Pharma, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03444844 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03444844's enrollment target sits among peer trials
60 421st of 735 higher than 293 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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